FDA Approves Gardasil Vaccine For Prevention Of Anal Cancer

The U.S. Food and Drug Administration announced today that it has approved Merck’s Gardasil vaccine for the prevention of human papillomavirus-related anal cancer in men and women ages 9 to 26 years.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Dr. Karen Midthun, director of the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, in a press release.

The Gardasil vaccine (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) is the first vaccine to be approved for prevention of anal cancer. It works by targeting human papillomavirus (HPV) strains 6, 11, 16, and 18, which are most commonly associated with anal and other cancers.

The approval is based on clinical trial results showing that the vaccine is 78 percent effective in preventing precancerous anal lesions caused by HPV strains 16 and 18. These strains are responsible for an estimated 80 percent of anal cancers.

Anal cancer is increasingly a problem in people with HIV, as HPV is much more likely to cause anal cancer in HIV-positive men and women. Researchers have estimated that people with HIV are 30 to 50 times more likely to get anal cancer than people without HIV. In men who have sex with men this number is even higher, around 60 times more likely.

Antiretroviral therapy has not been shown to decrease the rates of anal cancer in men and women with HIV.

To effectively prevent anal cancer, Gardasil must be given before HPV is contracted, preferably when a person has had little or no prior sexual contact. The vaccine is given as three injections over six months.

Gardasil was already approved for prevention of cervical, vulvar, and vaginal cancers in women, and prevention of genital warts in both men and women.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


TOGETHER WE REMAIN STRONG!